According to the Zhitong Finance APP, CUTIA-B (02487) announced that the group's CU-30101 (topical lidocaine-benzocaine cream) has obtained marketing authorization from the National Medical Products Administration of the People's Republic of China (NMPA).

CU-30101 is a topical lidocaine-benzocaine composite cream used for epidermal anesthesia procedures. Due to its unique pharmacokinetic properties, the combination formula of lidocaine and benzocaine in CU-30101 can produce rapid and long-lasting anesthetic effects. Lidocaine disperses faster and has a wider dispersion range than benzocaine, while benzocaine is a long-acting amino acid ester local anesthetic that is more lipophilic than lidocaine and can concentrate in the epidermal stratum corneum. Additionally, the topical cream formulation limits the systemic absorption of the anesthetic components, thus ensuring good safety.

The marketing authorization for CU-30101 is primarily based on the results of a Phase III clinical trial conducted in China. The results of this clinical trial showed that the analgesic efficacy of CU-30101 is comparable to that of the reference formulation Pliaglis® lidocaine-benzocaine cream (Pliaglis®), and the overall safety is good. The local tolerability assessment of CU-30101 is similar to that of Pliaglis®, and consistent with the known safety profile of Pliaglis®, with no new safety signals reported.

As the first product approved by the NMPA in the field of epidermal anesthesia for the group, and the third product approved following CU-10201 (topical 4% minocycline foam) and CU-40102 (topical finasteride spray), CU-30101 will facilitate the group's further expansion of sales channels and provide convenience for the commercialization access of subsequent products. Therefore, CU-30101 will further strengthen the group's commercialization layout in the broad skin disease treatment and care market